Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT03817190|
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : December 11, 2019
The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).
Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 200 subjects.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: DS107 Drug: Placebo||Phase 2|
This study involves a comparison of 2g DS107 with placebo, administered orally once daily for a total of 16 weeks. Patient will be randomized to one of the two treatment arms in a 1:1 ratio.
Patients will come to the clinic on 12 occasions: at Screening/Visit 1, Baseline/Visit 2, Week 2/Visit 3, Week 4/Visit 4, Week 6/Visit 5, Week 8/Visit 6, Week 10/Visit 7, Week 12/Visit 8, Week 14/ Visit 9, Week 16/Visit 10 (end of treatment), Week 18/ Visit 11 (follow up) and Week 20/Visit 12 (follow-up).
The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, BSA (Body Surface Area) and NRS (Numeric Rating Scale).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis|
|Actual Study Start Date :||September 19, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: 2g Oral DS107
2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks
Placebo Comparator: Placebo
Placebo (4 placebo capsules) orally administered once-daily for 16 weeks
- Validated Investigator Global Assessment (vIGA) [ Time Frame: 16 Weeks ]Proportion of patients achieving a vIGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points.
- Eczema Area Severity Index (EASI) [ Time Frame: 16 Weeks ]Proportion achieving EASI-75
- Validated Investigator Global Assessment (vIGA) [ Time Frame: 20 Weeks ]Proportion of patients achieving a vIGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points.
- Eczema Area Severity Index (EASI) [ Time Frame: 20 Weeks ]Proportion achieving EASI-75
- Numeric Rating Scale (NRS) [ Time Frame: 20 Weeks ]Proportion achieving a decrease of at least 4 points
- Body Surface Area [ Time Frame: Week 20 ]change from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817190
|Contact: Kirsty Kellyemail@example.com|
|Contact: Moayed Hamzafirstname.lastname@example.org|
|Study Chair:||Markus Weissbach, MD||DS Biopharma|